Effects of High Intensity Laser on Mechanical and Physiological Findings in Pregnant Women With Carpal Tunnel Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Changes in Distal latency of median nerve sensory distal latency
研究概览
简要总结
This study will propose a novel approach to treat pregnant women with mild to moderate carpal tunnel syndrome (CTS) using the recently introduced High intensity laser therapy with its deep penetration and high-power characteristics. It's hopeful that the results of this study can fill the gap of knowledge surrounding the conservative treatment options for CTS in order to help patients restore their nerve function properly and promote new ways of addressing CTS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Pregnant women with mild to moderate CTS diagnosed by a physician according to the American Association of Electrodiagnostic recent guidelines [18] (2) The age ranged between 20 to 40 years (3) Had positive clinical provocative tests for the CTS (Tinel test and Phalen test) and (5) Had a history of pain, paresthesia or numbness in the median nerve distribution, nocturnal pain, and night waking
排除标准
- •Patients were excluded from the study if they had cervical disc prolapse, cervical spondylosis, thoracic outlet syndrome, diabetes, gestational diabetes, cardiovascular disorders and hypertension. Patients who had carpal tunnel release surgery and patients who were diagnosed with CTS before pregnancy were also excluded from the study.
研究组 & 干预措施
Group A (High Intensity Laser therapy + Conventional Physical Therapy)
Patients in group (A) received conventional physical therapy program along with HILT. Patients received pulsed Nd: YAG laser treatment, produced by EXAND MY 1064 nm Laser system, Mectronic Medicale, Italy. The apparatus provided pulsed emission (1064 nm), very high peak power (3 kW), a high level of fluency (energy density; 360-1780 mJ/cm2).
干预措施: High intensity laser therapy (Device)
Group A (High Intensity Laser therapy + Conventional Physical Therapy)
Patients in group (A) received conventional physical therapy program along with HILT. Patients received pulsed Nd: YAG laser treatment, produced by EXAND MY 1064 nm Laser system, Mectronic Medicale, Italy. The apparatus provided pulsed emission (1064 nm), very high peak power (3 kW), a high level of fluency (energy density; 360-1780 mJ/cm2).
干预措施: Conventional Physical Therapy (Other)
Group B (Conventional Physical Therapy)
Patients in this group received the conventional physical therapy program in the form of splinting, tendon and neural gliding exercises. Patients were instructed to wear a neutral custom volar splint at night and while performing strenuous activities during the day for 5 weeks.Also, the patients performed nerve-and tendon-gliding exercise under direct supervision of the therapist during the treatment sessions. Each exercise was repeated 10 times at each session and patients were encouraged to apply exercise 3-5 times per day for 5 weeks.
干预措施: Conventional Physical Therapy (Other)
结局指标
主要结局
Changes in Distal latency of median nerve sensory distal latency
时间窗: Baseline and after 5 Weeks
The Median sensory nerve (SNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.
Changes in Distal latency of median nerve motor distal latency
时间窗: Baseline and after 5 Weeks
The Median motor nerve (MNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.
次要结局
- Changes in numeric pain rating scale (NPRS)(Baseline and after 5 Weeks)
- Changes in hand grip strength(Baseline and after 5 Weeks)
研究者
Mohamed Magdy Ali Hassan ElMeligie
Principal investigator
October 6 University